A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies

The TEMPUS AQUARIUS Study is a non-interventional, longitudinal observational study focused on hematological malignancies. It will collect rich molecular (multi-omic) and clinical data from patient cohorts through serial blood draws and the acquisition of leftover tissue and/or bone marrow aspirates during their routine therapy and disease monitoring. The primary goal is to understand the association between biomarkers and real-world clinical outcomes in these patient populations.

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Key information

Conditions

Acute Myeloid Leukaemia (AML) Follicular Lymphoma ( FL) Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Hospital and Clinics, Iowa City, Iowa, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All Cohorts Inclusion Criteria:

Willing and able to participate in the research and provide biospecimens
Willing and able to provide informed consent

Cohort 001 Inclusion:

Have documented diagnosis of AML according to the World Health Organization (WHO) classification
Secondary AML is allowed

Cohort 002 Inclusion:

Histologically confirmed diagnosis of Follicular Lymphoma (Subgroups A-D)
Submission of baseline sample representative of current disease per laboratory manual (Subgroups A-D)
002A (Newly Diagnosed Active Observation): On active observation for 6 more or less, or intended for active observation
002B (Newly Diagnosed, High Risk): Intended for first line treatment
002B (Newly Diagnosed, High Risk): Meets the criteria for high risk by any of the following: Follicular Lymphoma Inernational Prognostic Index (FLIPI) High Risk, Groupe d'Etude des Lymphomes Follicularies (GELF) High Tumor Burden, Lactate Dehydrogenase (LDH) above the upper limit of normal (ULN)
002C (Relapsed / Refractory High Risk POD24 FL): Documented progression of disease within 24 months (POD24) of first line follicular lymphoma treatment, prior to second line treatment
002D (Transformed FL): Pathologically confirmed transformation

All Cohorts Exclusion Criteria:

Not willing or able to adhere with the study procedures

Cohort 001:

Have received any prior therapy intended for standard of care (SoC) treatment of AML

Cohort 002:

002A: Received prior treatment for follicular lymphoma
002A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN
002A: Resected patients with NED
002B: Intended for active observation
002B: Received prior treatment for follicular lymphoma

Treatment and study plan

None - observational study

Other

There are no interventions in this observational study.

Primary outcomes

To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications.

Time frame: 5 years

The goal of this biomarker discovery registry is to assess DNA and RNA expression patterns and potential biomarkers in biospecimens collected at baseline and throughout treatment, with the goal of generating hypotheses about predictive markers for therapy selection, prognostic indicators, and potential mechanisms of resistance to standard-of-care therapies across multiple hematologic indications.

Study contacts

Contact information is provided by the study sponsor or research team.

Aquarius Clinical Study Manager

CONTACT

[email protected]

800-739-4137

Sponsors and collaborators

Lead sponsor

Tempus AI

Industry

Registry information

Acronym: Aquarius

Important dates

Study start: 2026
Primary completion: 2034
Study completion: 2035
First posted: Sep 4, 2025
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting